Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01106651




Registration number
NCT01106651
Ethics application status
Date submitted
1/04/2010
Date registered
20/04/2010
Date last updated
4/11/2014

Titles & IDs
Public title
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy
Secondary ID [1] 0 0
28431754DIA3010
Secondary ID [2] 0 0
CR017014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Canagliflozin 100 mg
Treatment: Drugs - Canagliflozin 300 mg
Treatment: Drugs - Antihyperglycemic agent(s)
Treatment: Drugs - Placebo

Experimental: Canagliflozin 100 mg - Each patient will receive 100 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Experimental: Canagliflozin 300 mg - Each patient will receive 300 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Placebo comparator: Placebo - Each patient will receive matching placebo once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.


Treatment: Drugs: Canagliflozin 100 mg
One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Treatment: Drugs: Canagliflozin 300 mg
One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Treatment: Drugs: Antihyperglycemic agent(s)
Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\] inhibitors, metformin, insulin \[all types\]) and their combinations (sulfonylurea agent and insulin \[all types\], metformin and insulin \[all types\], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\]) are used as per protocol specifications.

Treatment: Drugs: Placebo
One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c From Baseline to Week 26
Timepoint [1] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [1] 0 0
Percentage of Patients With HbA1c <7% at Week 26
Timepoint [1] 0 0
Week 26
Secondary outcome [2] 0 0
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Timepoint [2] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [3] 0 0
Percent Change in Body Weight From Baseline to Week 26
Timepoint [3] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [4] 0 0
Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Timepoint [4] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [5] 0 0
Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Timepoint [5] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [6] 0 0
Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Timepoint [6] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [7] 0 0
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Timepoint [7] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [8] 0 0
Percent Change in Triglycerides From Baseline to Week 26
Timepoint [8] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [9] 0 0
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Timepoint [9] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [10] 0 0
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26
Timepoint [10] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [11] 0 0
Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26
Timepoint [11] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [12] 0 0
Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26
Timepoint [12] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [13] 0 0
Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26
Timepoint [13] 0 0
Day 1 (Baseline) and Week 26

Eligibility
Key inclusion criteria
* All patients must have a diagnosis of T2DM and may be currently treated with a stable regimen of antihyperglycemic agent(s)
* Patients in the study must have a HbA1c between >=7 and <=10.0%
* Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
Minimum age
55 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
716
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Fremantle
Recruitment hospital [2] 0 0
- Heidelberg Heights
Recruitment hospital [3] 0 0
- Meadowbrook
Recruitment hospital [4] 0 0
- Richmond
Recruitment postcode(s) [1] 0 0
- Fremantle
Recruitment postcode(s) [2] 0 0
- Heidelberg Heights
Recruitment postcode(s) [3] 0 0
- Meadowbrook
Recruitment postcode(s) [4] 0 0
- Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
North Dakota
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Newfoundland and Labrador
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Colombia
State/province [21] 0 0
Barranquilla
Country [22] 0 0
Colombia
State/province [22] 0 0
Bogota
Country [23] 0 0
France
State/province [23] 0 0
Corbeil Essonnes
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Venissieux
Country [26] 0 0
Greece
State/province [26] 0 0
Thessalonikis
Country [27] 0 0
Greece
State/province [27] 0 0
Thessaloniki
Country [28] 0 0
Hong Kong
State/province [28] 0 0
Sha Tin
Country [29] 0 0
India
State/province [29] 0 0
Bangalore
Country [30] 0 0
India
State/province [30] 0 0
Nagpur
Country [31] 0 0
India
State/province [31] 0 0
Pune
Country [32] 0 0
New Zealand
State/province [32] 0 0
Auckland
Country [33] 0 0
New Zealand
State/province [33] 0 0
Christchurch
Country [34] 0 0
New Zealand
State/province [34] 0 0
Tauranga
Country [35] 0 0
New Zealand
State/province [35] 0 0
Wellington
Country [36] 0 0
Poland
State/province [36] 0 0
Katowice
Country [37] 0 0
Poland
State/province [37] 0 0
Krakow
Country [38] 0 0
Poland
State/province [38] 0 0
Torun
Country [39] 0 0
Poland
State/province [39] 0 0
Warszawa
Country [40] 0 0
Poland
State/province [40] 0 0
Wroclaw
Country [41] 0 0
Romania
State/province [41] 0 0
Bucharest
Country [42] 0 0
Romania
State/province [42] 0 0
Sibiu
Country [43] 0 0
South Africa
State/province [43] 0 0
Pretoria
Country [44] 0 0
Spain
State/province [44] 0 0
Granada
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
Pozuelo De Alarcon
Country [47] 0 0
Spain
State/province [47] 0 0
Sevilla
Country [48] 0 0
Sweden
State/province [48] 0 0
Göteborg
Country [49] 0 0
Sweden
State/province [49] 0 0
Uppsala
Country [50] 0 0
Switzerland
State/province [50] 0 0
Bruderholz
Country [51] 0 0
Switzerland
State/province [51] 0 0
St Gallen
Country [52] 0 0
Ukraine
State/province [52] 0 0
Kharkov
Country [53] 0 0
Ukraine
State/province [53] 0 0
Kiev
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Birmingham
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Cardiff
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Glasgow
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Liverpool
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Manchester
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Reading
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01106651